Devices, systems and methods for treating pain with electrical stimulation

• US 10,413,723 B2
• Filed: 08/18/2017
• Issued: 09/17/2019
• Est. Priority Date: 09/22/2011
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: DJO LLC (Enovis Corp.)
• Inventors: Bachinski, Thomas Jerome, Silvola, Dain, Moore, Michael, Dave, Jay, Winn, Joseph
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US15/681,177
• Publication Number:
  US 20180064939A1
• Time in Patent Office: 760 Days
• CPC Class Codes: A61H 2201/0153 hand-held
• CPC Class Codes: A61H 2201/0157 portable
• CPC Class Codes: A61H 2201/0184 by raising an alarm
• CPC Class Codes: A61H 2201/0188 Illumination related features
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/1604 Head
• CPC Class Codes: A61H 2201/1609 Neck
• CPC Class Codes: A61H 2201/1635 Hand or arm, e.g. handle hand-held, A61H2201/0153; fore-arm support, A61H2003/006
• CPC Class Codes: A61H 2201/1685 interchangeable modular devices, A61H2201/0107
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/501 connected to external computer devices or networks
• CPC Class Codes: A61H 2201/5012 using the internet
• CPC Class Codes: A61H 2201/5028 Contact activation, i.e. activated at contact with a surface of the user to be treated
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5048 Audio interfaces, e.g. voice or music controlled
• CPC Class Codes: A61H 2201/5082 Temperature sensors
• CPC Class Codes: A61H 2205/02 Head
• CPC Class Codes: A61H 2205/022 Face
• CPC Class Codes: A61H 2205/04 neck
• CPC Class Codes: A61H 2205/062 : Shoulders
• CPC Class Codes: A61H 2205/065 : Hands
• CPC Class Codes: A61H 2205/081 : Back
• CPC Class Codes: A61H 2205/10 : Leg
• CPC Class Codes: A61H 2205/12 : Feet
• CPC Class Codes: A61H 2230/065 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/605 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/655 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 23/02 : with electric or magnetic drive
• CPC Class Codes: A61H 39/002 : Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61H 39/04 : Devices for pressing such points, e.g. Shiatsu or AcupressureMassage or pressure on general areas A61H9/00 - A61H23/00
• CPC Class Codes: A61H 39/08 : Devices for applying needles to such points, i.e. for acupuncture ; Acupuncture needles or accessories therefor
• CPC Class Codes: A61N 1/0456 : Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware

Abstract

Devices, systems and methods are provided for treating migraine headaches and other conditions by non-invasive electrical stimulation of nerves and other tissue. A hand-held device includes a housing with a controller having a signal generator, an electrode for delivering electrical signals, and a conductive surface configured as a return path for the electrical signals. In certain implementations, the electrode is repositionable with respect to the housing. The patient can self-apply the hand-held device by pressing it against areas in need of pain relief. The device may include a pressure-sensitive gating switch to control delivery of the stimulation therapy. In certain embodiments, the electrode is a rollerball electrode. The device may include a chamber for retaining and dispensing conductive gel to the therapy site. In certain approaches, the device includes an electrode support for coupling an electrical stimulation system to the head for hands-free electrical stimulation therapy.

Claims

1. A method of delivering electrical stimulation to a patient using a device comprising a housing, a conductive surface disposed on an outer surface of the housing, and an electrode that is repositionable with respect to the housing, the method comprising:

in a programmable processor disposed within the housing, generating stimulation control signals based on waveform information received in the processor;

in a signal generator disposed within the housing, receiving the stimulation control signals and generating corresponding electrical stimulation waveforms, the signal generator comprising a first signal line and a second signal line;

contacting a surface of the electrode and the conductive surface to the patient, the conductive surface in electrical communication with the first signal line of the signal generator;

moving the electrode between a first position that is not in electrical communication with the second signal line and a second position that is in electrical communication with the second signal line; and

transmitting the electrical stimulation waveforms through the electrode to a nerve beneath the patient'"'"'s skin when the electrode is in the second position.

2. The method of claim 1, wherein transmitting the electrical stimulation waveforms comprises transmitting electrical stimulation waveforms having predetermined amplitudes and fixed frequencies.

3. The method of claim 1, further comprising varying the electrical stimulation waveforms in response to waveform information received in the processor.

4. The method of claim 1, wherein the waveform information includes at least one of frequency, amplitude, pulse width, pulse shape, and duration of the electrical stimulation waveforms.

5. The method of claim 1, further comprising receiving the waveform information in the processor via a port in the outer surface of the housing.

6. The method of claim 1, further comprising:

using the waveform information received in the processor, programming the processor to adjust the electrical stimulation waveforms over a specific time according to a programmed schedule.

7. The method of claim 1, wherein the waveform information received in the processor includes stimulation protocols in a prescribed treatment regimen, and wherein the method further comprises:

programming the processor to adjust the electrical stimulation waveforms according to the prescribed treatment regimen.

8. The method of claim 1, further comprising programming the processor to output stimulation control signals that generate a first, low frequency electrical stimulation waveform followed by a second, high amplitude electrical stimulation waveform.

9. The method of claim 1, further comprising transmitting the waveform information from an external source to the processor through a port in the outer surface of the housing.

10. The method of claim 9, further comprising:

using the waveform information received in the processor through the port, programming the processor to adjust at least one characteristic of the electrical stimulation waveforms.

11. The method of claim 9, wherein the processor receives the waveform information from a USB connection through the port.

12. The method of claim 1, further comprising:

wirelessly receiving the waveform information in the processor from an external source; and

using the waveform information, programming the processor to adjust at least one characteristic of the electrical stimulation waveforms.

13. A method of treating a headache, comprising:

positioning a first electrode on skin at a location near a patient'"'"'s occipital nerve;

electrically coupling the first electrode to a second electrode;

applying pressure to the first electrode, wherein the first electrode translates along an axis to complete an electrical communication path with a signal generator; and

delivering current through the first electrode to thereby stimulate the occipital nerve.

14. The method of claim 13, wherein the first electrode is a conductive surface extending from a housing, and wherein the method further comprises:

in a programmable processor disposed within the housing, generating stimulation control signals based on stimulation protocols received in the processor;

in the signal generator disposed within the housing;

receiving the stimulation control signals,

generating corresponding electrical stimulation waveforms, and

delivering the current through the first electrode in accordance with the electrical stimulation waveforms.

15. The method of claim 14, further comprising receiving the stimulation protocols in the processor through a port in an exterior surface of the housing.

16. The method of claim 15, wherein the stimulation protocols received in the processor through the port program the processor to adjust at least one of frequency, amplitude, pulse width, pulse shape, and duration of the electrical stimulation waveforms.

17. The method of claim 13, further comprising adjusting the level of current delivered through the first electrode.

18. The method of claim 13, wherein applying pressure to translate the first electrode closes a switch and delivers the current.

19. The method of claim 13, further comprising positioning the second electrode on a portion of the skin of the patient.

20. The method of claim 13, further comprising applying a conductive gel to the skin from a surface of the first electrode, wherein the first electrode is positioned within a housing, and wherein the conductive gel flows from a chamber within the housing to the first electrode and from the first electrode to the skin.